Nonprescription Drugs Advisory Committee; Notice of Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Nonprescription Drugs Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on December 14, 2007, from 8 a.m. to 5 p.m.

Addresses: Electronic comments should be submitted to http://www.fda.gov/dockets/ecomments . Select “2007P-0047—Amend the Dosage of Oral Phenylephrine Listed in the Final Monograph on Oral Decongestants,” and follow the prompts to submit your statement. Written comments should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, by close of business on December 30, 2007.

Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727 Colesville Rd., Silver Spring, MD. The hotel telephone number is 301-589-5200.

Contact Person; Diem-Kieu Ngo, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: Diem.Ngo@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301) 443-0572 in the Washington, DC area), code 3014512541. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency's Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

Agenda: The committee will discuss the safety and effectiveness of phenylephrine hydrochloride and phenylephrine bitartrate as over-the-counter (OTC) oral nasal decongestants. The discussion at the meeting will address a citizen petition submitted to FDA on February 1, 2007 (Docket No. 2007P-0047/CP1), which asserts that the available data do not support the adult and pediatric doses of phenylephrine hydrochloride and phenylephrine bitartrate that are generally recognized as safe and effective in the OTC drug monograph for Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products (CCABADP) in 21 CFR part 341. The meeting will focus on the review of existing safety and efficacy data and the petitioner's request that the CCABADP monograph be amended to increase the adult dose of phenylephrine hydrochloride from 10 to 25 milligrams (mg) and that of phenylephrine bitartrate from 15.6 to 40 mg.

Additional information was submitted to the docket for OTC Nasal Decongestants (Docket No. 1976N-0052N; submissions EMC140, C251, C253 and Supplement 13) and is related to the petition or the petitioner's publications. These submissions were submitted to the OTC Nasal Decongestant docket and have been cross-referenced and linked to Docket No. 2007P-0047. The petition and other relevant submissions can be found at the following Web site: http://www.fda.gov/ohrms/dockets/dockets/07p0047/07p0047.htm .

Other information in Docket No. 1976N-0052N may be considered. For example, see comments 10 and 11 of the Tentative Final Monograph for OTC Nasal Decongestants, published in the Federal Register of January 15, 1985 (50 FR 2220 at 2226).

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material will be available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm , click on the year 2007 and scroll down to the appropriate advisory committee link.

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before November 30, 2007. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before November 22, 2007. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by November 23, 2007.

Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Diem-Kieu Ngo at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/default.htm for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).